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Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

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ClinicalTrials.gov Identifier: NCT00739310
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : September 24, 2015
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hill-Rom

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cerebral Palsy
Intervention Device: Vest Treatment (high frequency chest wall oscillation)
Enrollment 29

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vest Treatment (HFCWO)
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Patients will receive Vest treatments for airway clearance therapy 2 x daily

Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes

Period Title: Overall Study
Started 29
Completed 22
Not Completed 7
Reason Not Completed
Poor adherance to prescribed therapy             4
Withdrawal by Subject             1
Lost to Follow-up             2
Arm/Group Title Vest Treatment (HFCWO)
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Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.

Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes

Overall Number of Baseline Participants 22
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Patients who completed 12 months of prospective therapy
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
9.55  (5.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
8
  36.4%
Male
14
  63.6%
1.Primary Outcome
Title Hospitalizations Lasting at Least 24 Hours in This Patient Population
Hide Description Hospitalizations lasting at least 24 hours
Time Frame end of study
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-Treatment Post Vest Treatment
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Prior to Vest Treatment
12 months of intervention 2 x daily Vest Therapy
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: hospitalizations
10 8
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vest Treatment (HFCWO)
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Patients will receive Vest treatments for airway clearance therapy 2 x daily

Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes

All-Cause Mortality
Vest Treatment (HFCWO)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vest Treatment (HFCWO)
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vest Treatment (HFCWO)
Affected / at Risk (%)
Total   0/29 (0.00%) 
Study design was sub-optimal due to lack of control group and lack of randomization
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kathryn Fitzgerald, NP
Organization: Maimonides, Department of Pulmonary Medicine
Phone: 718-283-7339
Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00739310     History of Changes
Other Study ID Numbers: CR-0088
First Submitted: August 20, 2008
First Posted: August 21, 2008
Results First Submitted: April 20, 2015
Results First Posted: September 24, 2015
Last Update Posted: August 7, 2017